Product Name & Indications Section
ACNE~CYSTIC ACNE Formulated for symptoms associated with acne and other skin conditions such as boils, pimples, pustules and sebaceous cysts.
Acne Cystic Acne
FDA Label NDC 55714-4468
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Newton Laboratories, Inc. for the product Acne Cystic Acne (NDC 55714-4468). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding product name & indications section, direction section, active ingredient section, purpose section, inactive ingredient section, questions? section, warnings section, pregnancy or breast feeding section, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Direction Section
Directions: ORAL USE ONLY - SHAKE WELL. Ages 12 and up, take 6 drops (ages 0 to 11, give 3 drops) one to four times daily or as directed by a healthcare professional.
Active Ingredient Section
Antimon. crud. 15x, Arsenicum alb.5x, Aur. met. 15x, Berber. aqui. 15x, Bovista 15x, Carbo veg. 15x, Causticum 15x, Chelidonium majus 15x, Dulcamara 15x, Graphites 15x, Hepar sulph. calc. 15x, Hydrocotyle 15x, Kali brom. 15x, Kali iod. 15x, Ledum 15x, Lycopodium 15x, Nux vom. 15x, Silicea 15x, Sulphur iod. 15x, Zinc. met. 15x, Echinacea 3x, Juglans regia 3x, Lappa 3x, Taraxacum 3x.
Purpose Section
Formulated for symptoms associated with acne and other skin conditions such as boils, pimples, pustules and sebaceous cysts.
Inactive Ingredient Section
Inactive Ingredients: USP Purified Water; USP Gluten-free, non-GMO, organic cane dispensing alcohol 20%.
Questions? Section
www.newtonlabs.net Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012
Questions? 1.800.448.7256
Warnings Section
Warning: Do not use if tamper - evident seal is broken or missing. Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days. Keep out of reach of children.
Pregnancy Or Breast Feeding Section
Consult a licensed healthcare professional if pregnant or nursing or if symptoms worsen or persist for more than a few days.
Keep Out Of Reach Of Children Section
Keep out of reach of children.
Package Label.
Package Label (R035 L01)
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